UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054608 |
|---|---|
| Receipt number | R000062391 |
| Scientific Title | A study on the usefulness of preoperative stoma site marking with eyeliner |
| Date of disclosure of the study information | 2024/06/10 |
| Last modified on | 2024/12/07 10:41:45 |
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Basic information
Public title
A study on the usefulness of preoperative stoma site marking with eyeliner
Acronym
A study on the usefulness of preoperative stoma site marking with eyeliner
Scientific Title
A study on the usefulness of preoperative stoma site marking with eyeliner
Scientific Title:Acronym
A study on the usefulness of preoperative stoma site marking with eyeliner
Region
| Japan |
Condition
Condition
Patients undergoing surgery including intestinal stoma construction
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For patients undergoing a procedure involving the construction of an intestinal stoma, we compared the durability of stoma site marking methods using a conventional oil-based pen and a method using eyeliner, which is commonly used as a cosmetic, and examined their usefulness.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of stoma site markings confirmed by surgeons during stoma construction
Key secondary outcomes
allergic complication rate
postoperative infection rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Maneuver |
Interventions/Control_1
Following the Cleveland Clinic stoma site marking method, surgeons and nurses mark the stoma site on the patient's abdomen at the stoma construction site using a water-based pen and an oil-based pen, one on each side of the abdomen. For emergency surgery cases, stoma site marking is performed immediately before surgery. For stoma site marking, a photograph of the abdomen is taken with a digital camera and the stoma site marking site is recorded. On the morning of the day of surgery, a 3cm circular stoma site marking is performed at the site where stoma site marking was performed the previous day with an oil-based pen.
In the operating room, after general anesthesia is induced, another doctor who has not performed stoma site marking disinfects the abdomen with povidone iodine. The patient is covered with a drape and the surgeon evaluates whether the stoma site markings on the left and right abdomen can be confirmed just before operating.
Just before constructing a stoma, the surgeon evaluates again whether the stoma site markings can be confirmed.
In order to maintain objectivity, the evaluation of stoma site marking is scored using a point system. The following definitions apply: 2 points for fully confirmed stoma site marking, 1 point for barely confirmed stoma site marking, and 0 point for difficult to confirm stoma site marking.
Interventions/Control_2
Following the Cleveland Clinic stoma site marking method, surgeons and nurses mark the stoma site on the patient's abdomen at the stoma construction site using a water-based pen and an oil-based pen, one on each side of the abdomen. For emergency surgery cases, stoma site marking is performed immediately before surgery. For stoma site marking, a photograph of the abdomen is taken with a digital camera and the stoma site marking site is recorded. On the morning of the day of surgery, a 3cm circular stoma site marking is performed at the site where stoma site marking was performed the previous day with an eyeliner.
In the operating room, after general anesthesia is induced, another doctor who has not performed stoma site marking disinfects the abdomen with povidone iodine. The patient is covered with a drape and the surgeon evaluates whether the stoma site markings on the left and right abdomen can be confirmed just before operating.
Just before constructing a stoma, the surgeon evaluates again whether the stoma site markings can be confirmed.
In order to maintain objectivity, the evaluation of stoma site marking is scored using a point system. The following definitions apply: 2 points for fully confirmed stoma site marking, 1 point for barely confirmed stoma site marking, and 0 point for difficult to confirm stoma site marking.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The subjects are patients who are scheduled to have a permanent or temporary stoma for lower rectal cancer, or patients who have developed peritonitis due to lower gastrointestinal perforation and are scheduled to have a stoma.
Key exclusion criteria
Cases with active bleeding such as abdominal stab wounds and cases with a history of multiple laparotomies in which it is difficult to perform two stoma site markings
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Chihiro |
| Middle name | |
| Last name | Kosugi |
Organization
Teikyo University Chiba Medical Center
Division name
Department of Surgery
Zip code
299-0111
Address
Department of Surgery
TEL
0436621211
ckosugi0126@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Chihiro |
| Middle name | |
| Last name | Kosugi |
Organization
Teikyo University Chiba Medical Center
Division name
Department of Surgery
Zip code
2990111
Address
3426-3 Anesaki, Ichihara, Chiba, Japan
TEL
0436621211
Homepage URL
ckosugi0126@yahoo.co.jp
Sponsor or person
Institute
Department of Surgery, Teikyo University Chiba Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee, Teikyo University
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
Tel
0436621211
ckosugi0126@yahoo.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
帝京大学ちば総合医療センター（千葉県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2024 | Year | 06 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 07 | Day |
Last modified on
| 2024 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062391
